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Background: The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns., Hypothesis: The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups., Study Design: The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization., Summary: The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria., (© 2013.)

Background: No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions., Methods: Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months., Results: The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group., Conclusions: A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: The aim of the study was to compare the outcomes of sirolimus-eluting (SES) and paclitaxel-eluting (PES) stent implantation in coronary bifurcations treated with either a 1-stent or 2-stent strategy., Methods: The study used a retrospective cohort analysis of consecutive de novo bifurcations, excluding left main, treated with SES or PES between April 2003 and June 2005., Results: We identified 170 bifurcations in 161 patients treated with SES and 119 bifurcations in 112 patients treated with PES. During a median follow-up of 1,061 days (interquartile range 814-1,314), 43 patients (26.7%) in the SES group and 28 (25.0%) in the PES group had a major adverse cardiac event (P = .78). The angiographic restenosis rate per bifurcation was 20.9% and 25.9%, respectively (P = .41). There was no difference overall in the occurrence of target lesion revascularization (TLR) per bifurcation, 22 with SES (12.9%) and 18 with PES (15.1%), P = .61. The TLR rate was similar for SES and PES in bifurcations treated with 1 stent (6.7% vs 11.4%, P = .40) and in bifurcations treated with both branch stenting (20.0% vs 20.4%, P =1.0)., Conclusions: In this cohort, the long-term clinical outcomes appear similar overall between SES and PES in the treatment of coronary bifurcations irrespective of whether a 1-stent or 2-stent strategy was used.

Background: Currently, little data are available on the management of drug-eluting stent (DES) restenosis. Drug resistance may play a role in its etiology., Methods: We identified all cases of either sirolimus-eluting or paclitaxel-eluting stent restenosis treated with repeated DES implantation. The lesions were divided into those receiving the same DES as the one that restenosed and those treated with the alternative DES. The end points analyzed were target lesion revascularization (TLR) and angiographic restenosis., Results: We included 201 lesions (174 patients); the same DES was implanted in 107 lesions and a different DES in 94 lesions. Angiographic follow-up of the retreatment was available in 69.7% of the lesions. Angiographic restenosis occurred in 26.4% (19) of cases treated with the same DES and 25.8% (17) of those treated with a different DES (P = 1.0). Target lesion revascularization occurred in 15.9% (17) and 16% (15) of lesions, respectively (P = 1.0). A multivariate analysis confirmed the lack of association between the treatment selected and TLR (OR 0.7, 95% CIs [0.29-1.67]; P = .42). A nonfocal pattern of restenosis remained associated with TLR and restenosis (OR 2.99, 95% CIs [1.24-7.24]; P = .015 and OR 3.6, 95% CIs [1.5-8.8]; P = .004, respectively)., Conclusions: Repeated DES implantation for DES restenosis is feasible and safe. The TLR rate is acceptable, with no differences between implantation of the same or a different DES. The pattern of restenosis treated is an important predictor of outcomes.

Background: Elective intraaortic balloon pump (IABP) may reduce acute complications during unprotected left main (ULM) stenting. However, few data exist on criteria for elective IABP support during ULM stenting., Methods: Since January 1993, 219 consecutive patients underwent elective ULM stenting: 69 had elective IABP support (elective IABP group), whereas 150 patients had conventional procedure (conservative group). Criteria for elective IABP support were (1) lesion located in the distal segment of the left main (bifurcation lesion), (2) left ventricular ejection fraction <40%, (3) atherectomy, (4) unstable angina, and (5) critical disease of the right coronary artery. Incidence of intraprocedural major adverse cardiac events (eg, severe hypotension and/or shock, myocardial infarction, urgent bypass surgery, and death) was assessed., Results: Euroscore >6 (identifying high-risk patients) occurred in 38% in the elective IABP group and 13% in the conservative group (P < .001). Severe hemodynamic instability occurred in 12 patients (8%) in the conservative group and in none in the elective IABP group (P = .020). Intraprocedural major adverse cardiac event was higher in the conservative group (9.5% vs 1.5%, P = .032). Elective IABP support (OR 0.08, 95% CI 0.01-0.69, P = .022) and presence of Euroscore >6 plus bifurcation lesion (OR 5.49; 95% CI 1.47-20.51; P = .011) were the independent predictors of intraprocedural events., Conclusions: Elective IABP may prevent intraprocedural events in elective ULM stenting, especially in patients at higher risk.

Background: Restenosis rate is lower after sirolimus-eluting stent (SES) implantation than after bare metal stent (BS) implantation. We evaluated the impact of SES implantation on immediate and 12-month outcome in diabetic patients with multivessel coronary artery disease (MVD)., Methods: From April 2002 to September 2003, 100 consecutive diabetic patients with MVD without previous myocardial revascularization underwent successful elective percutaneous coronary intervention (PCI) with SES on native coronary arteries at our institutions. A group (n = 122) of consecutive diabetic patients with MVD treated with BS implantation (BS group) for de novo lesions was selected from our database and matched with the SES group. Major adverse cardiac events (MACEs) during hospital stay and at follow-up included nonfatal myocardial infarction, death, bypass surgery, and re-PCI., Results: At 12 +/- 4 months, MACEs occurred in 25% of patients in the SES group and in 44% of those in the BS group (P = .003, OR .72, 95% CI 0.57-0.91). Need for repeat intervention (re-PCI or bypass surgery) occurred in 17% of patients in the SES group and in 41% of those in the BS group (P < .001, OR .67, 95% CI 0.52-0.86). No significant difference in the rate of death and myocardial infarction was observed. In the SES group, the independent predictors of MACEs at follow-up were premature clopidogrel discontinuation (hazard ratio 20.62, 95% CI 1.60-264.97, P = .020) and chronic renal insufficiency (hazard ratio 4.73, 95% CI 1.99-11.25, P = .0004)., Conclusions: As compared with BS implantation, SES implantation favorably influences outcome in diabetic patients with MVD, mainly by reducing the need for new revascularization.

Background: Doppler of mitral and pulmonary vein flows are used to estimate left ventricular (LV) filling pressure. Mitral regurgitation (MR) makes unreliable these parameters by inducing changes of both mitral inflow and pulmonary vein flow., Objectives: To evaluate whether Doppler tissue imaging (DTI) diastolic indices obtained at the level of LV lateral mitral annulus can provide accurate estimation of LV filling pressure in patients with MR., Methods: Forty-three patients (age 55 +/- 11 years) with severe MR and mean LV ejection fraction (EF) 58 +/- 13 were enrolled, 10 (23%) with LV EF < 50% and 33 (77%) with LV EF > 50%. Doppler signals from the mitral inflow, pulmonary venous flow, and DTI indices of the lateral mitral annulus were obtained. LV end-diastolic pressure (LVEDP) was measured invasively with fluid-filled catheter., Results: In the overall population, the majority of standard Doppler and DTI indices correlated with LVEDP, but the multivariate analysis showed that the ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/Em ratio) (beta = .87, P = .0001) was independent predictor of LVEDP (R2 = 0.74, SE = 4, P = .0001). An E/Em ratio > 10 predicted an LVEDP > 15 mm Hg (sensitivity 90%, specificity 83%). In both groups with LV EF > 50% (beta = .77, P = .005; cumulative R2 = 0.73, SE = 2.5, P = .0001) and < 50% (beta = .89, P = .002; cumulative R2 = 0.77, SE = 2.1, P = .002), multivariate analysis underscored again only E/Em ratio as independent predictor of LVEDP., Conclusions: The combination of DTI indices of the mitral annulus and mitral inflow velocities provides reliable parameters to predict LV filling pressure in patients with MR both in patients with LV EF > 50% and < 50%.

Background: Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI., Objective: The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty., Methods: The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age > or =75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups., Results: Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005., Conclusion: This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

Background: Elective intra-aortic balloon pump (IABP) support may reduce acute complications occurring during percutaneous coronary interventions (PCI) in patients with severe depression of the left ventricular ejection fraction (EF < or = 30%)., Methods: Since February 1998, 133 consecutive patients with EF < or =30% underwent elective PCI in our institution; 61 had elective preprocedural IABP support (group A) and 72 patients had conventional PCI (group B). Jeopardy score was calculated in each patient from the coronary angiograms to quantify the myocardium at risk., Results: EF was similar in the 2 groups. Jeopardy score was higher in group A (8.0 +/- 2.8 vs 6.7 +/- 2.4, P =.008). The other principal clinical and angiographic characteristics were similar in the 2 groups. Severe hypotension and/or shock occurred in 11 patients, all in group B (P =.001). All required urgent IABP support, and 3 eventually died. Intraprocedural major adverse cardiac and cerebral events (eg, myocardial infarction, severe hypotension and/or shock, urgent bypass surgery, stroke, and death) were higher in group B (17% vs 0%, P =.001). By stepwise logistic regression analysis, elective IABP support (odds ration [OR] 0.11 [95% CI 0.21-0.60], P =.011), jeopardy score (OR 5.37 [95% CI 1.10-8.70], P =.040), and female sex (OR 2.72 [95% CI 1.85-3.10], P =.015), were the correlates of intraprocedural events., Conclusions: This study supports the potential usefulness of elective versus provisional IABP to prevent intraprocedural major adverse cardiac and cerebral events in high-risk PCI.